FDA.reportPublic FDA data

Clean Safety

Primary DI
10851685006026
Brand
Clean Safety
Company
CLEAN SAFETY INC.
Model
CS4102
Device description
IRIS BLUE NITRILE POWDER FREE GLOVE - MEDIUM 1/10/200
Published
2020-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851685006029PackageGS110In Commercial Distribution
10851685006026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851685006029008516850060298516850060290851685006029
1085168500602610851685006026

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
079147322
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859116003029Clean SafetyCS20012024-09-03
00859116003012Clean SafetyCS20022020-05-15
00859116003036Clean SafetyCS20032020-05-15
00859116003043Clean SafetyCS20042020-05-15
00818420020443Clean SafetyCS49012022-07-28
00818420020542Clean SafetyCS46022022-07-28
00818420020566Clean SafetyCS46042022-07-28
00818420020856Clean SafetyCS49022022-07-28
00818420020979Clean SafetyCS49032022-07-28
00818420020993Clean SafetyCS49042022-07-28
00818420021013CLEAN SAFETYCS49002022-07-28
00818420021143Clean SafetyCS45052022-07-28
00818420020511Clean SafetyCS46002022-07-28
00818420020535Clean SafetyCS46012022-07-28
00818420020559Clean SafetyCS46032022-07-28
00859116003159Clean SafetyCS45002020-04-30
00859116003166Clean SafetyCS45012020-04-30
00859116003173Clean SafetyCS45022020-04-30
00859116003180Clean SafetyCS45032020-04-30
00859116003197Clean SafetyCS45042020-04-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
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00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
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00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641279Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641286Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641309Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641316Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZA2026-07-31